Evidence map›Paper›PMID 30373616›Full record

ArticleVirology journal2018

Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening.

Ajmal Akbari, Davy Vanden Broeck, Ina Benoy, Elizaveta Padalko, Johannes Bogers, Marc Arbyn

Abstract readValidation Study
In one paragraph

Article in Virology journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Ajmal AkbariAMBIOR, Laboratory for Cell Biology & Histology, University of Antwerp, Antwerp, Belgium.
Davy Vanden BroeckAMBIOR, Laboratory for Cell Biology & Histology, University of Antwerp, Antwerp, Belgium. Davy.vandenbroeck@aml-lab.be.ORCID 0000-0001-9381-4158
Ina BenoyAMBIOR, Laboratory for Cell Biology & Histology, University of Antwerp, Antwerp, Belgium.
Elizaveta PadalkoNational Reference Centre for HPV, Brussels, Belgium.
Johannes BogersAMBIOR, Laboratory for Cell Biology & Histology, University of Antwerp, Antwerp, Belgium.
Marc ArbynUnit of Cancer Epidemiology & Belgian Cancer Centre, Sciensano, Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCervical cancer screening with assays detecting DNA of high-risk human papillomavirus (hrHPV) types is more effective than cytology-based screening. This study completes the diagnostic accuracy assessment conducted previously within the framework of VALGENT-2 (Validation of HPV genotyping Tests) and aims to determine whether the reproducibility of Xpert HPV is in line with international validation criteria.

methodsValidation of new hrHPV DNA assays requires demonstration of good reproducibility and non-inferior clinical accuracy for cervical precancer compared to a standard comparator assay. The international reproducibility criteria are: lower bound of 95% confidence interval of the intra- and inter-laboratory agreement regarding detection of high-risk HPV DNA exceeding 87% with kappa ≥0.5.

resultsThe Xpert HPV assay showed high intra-laboratory reproducibility with an overall positivity/negativity agreement of 96.9% and a kappa of 0.925. Inter-laboratory testing showed an agreement of 97.8% with a kappa of 0.948.

conclusionsThe Xpert HPV assay fulfills the HPV test reproducibility criterion requirement for use in cervical cancer screening.

Indexed as

Human Papillomavirus DNA TestsConfidence IntervalsDNA, ViralEarly Detection of CancerFemaleGenotyping TechniquesHumansMass ScreeningPapillomaviridaePapillomavirus InfectionsPractice Guidelines as TopicReproducibility of ResultsSensitivity and SpecificityUterine Cervical NeoplasmsDNA, ViralCervical cancer screeningHuman papillomavirusReal-time sequencing

Identifiers

PMID30373616
PMCPMC6206920

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.